Objective. To estimate the minimum clinically important improvement (MCII) and patient acceptable symptom state (PASS) values for 4 generic outcomes in 5 rheumatic diseases and 7 countries.Methods. We conducted a multinational (Australia, France, Italy, Lebanon, Morocco, Spain, and The Netherlands) 4-week cohort study involving 1,532 patients who were prescribed nonsteroidal antiinflammatory drugs for ankylosing spondylitis, chronic back pain, hand osteoarthritis, hip and/or knee osteoarthritis, or rheumatoid arthritis. The MCII and PASS values were estimated with the 75th percentile approach for 4 generic outcomes: pain, patient global assessment, functional disability, and physician global assessment, all normalized to a 0 -100 score. Results. For the whole sample, the estimated MCII values for absolute change at 4 weeks were ؊17 (95% confidence interval [95% CI] ؊18, ؊15) for pain; ؊15 (95% CI ؊16, ؊14) for patient global assessment; ؊12 (95% CI ؊13, ؊11) for functional disability assessment; and ؊14 (95% CI ؊15, ؊14) for physician global assessment. For the whole sample, the estimated PASS values were 42 (95% CI 40, 44) for pain; 43 (95% CI 41, 45) for patient global assessment; 43 (95% CI 41, 44) for functional disability assessment; and 39 (95% CI 37, 40) for physician global assessment. Estimates were consistent across diseases and countries (for subgroups >20 patients). Conclusion. This work allows for promoting the use of values of MCII (15 of 100 for absolute improvement, 20% for relative improvement) and PASS (40 of 100) in reporting the results of trials of any of the 5 involved rheumatic diseases with pain, patient global assessment, physical function, or physician global assessment used as outcome criteria.

Objective. To determine the most appropriate means to assess the response to treatment in terms of pain and functional impairment in a chronic rheumatic condition (knee osteoarthritis [OA]) and an acute rheumatic condition (rotator cuff syndrome [RCS]). Methods. Two prospective studies were conducted consisting of 1,019 outpatients with knee OA and 271 patients with acute RCS. The minimal clinically important improvement and the patient acceptable symptom state were determined for knee OA pain using a visual analog scale, and for knee OA function using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale; for acute RCS pain, a numeral rating scale was used, and the Neer function subscale was used for RCS function. Results. The minimal clinically important improvement was shown to be the change required to achieve the patient acceptable symptom state, whatever the baseline level of symptom, the outcome (pain or function), or type of condition (chronic or acute). This acceptable state for pain was higher for chronic (27.0 -36.4 across the baseline score) than acute (16.7-24.1) conditions. The level of functional impairment considered satisfactory by patients with knee OA was higher for more disabled patients (43.1) than for less disabled patients (20.4). Conclusion. Patients consider that they experienced an important improvement only if this improvement allowed them to achieve a state they consider satisfactory. The most appropriate means to assess the response to therapy seems to be to assess whether patients feel good (i.e., achieve the patient acceptable symptom state).

Objective. To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug (NSAID)-refractory nonradiographic axial spondyloarthritis (SpA).Methods. The study population consisted of patients who met the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA but not the modified New York radiographic criteria for ankylosing spondylitis (as assessed by a radiologist at the central trial site), had a symptom duration of >3 months but <5 years, had a score of >4 on the Bath Ankylosing Spondylitis Disease Activity Index, and had been treated unsuccessfully with >2 NSAIDs. Patients were randomized to receive etanercept 50 mg/week or placebo and continued background NSAID treatment for 12 weeks (double-blind study); ClinicalTrials.gov identifier: NCT01258738.

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